Evaluation of the Efficacy and Safety of Intravenous Imipenem/Cilastatin/XNW4107 in Comparison With Meropenem in Hospitalized Adults With cUTI Including AP (EudraCT no. 2022-000061-40)

NCT05204368 | Unknown Phase 3 FDA Drug

• 1 other identifier: XNW4107-301
• Study Type: interventional
• Target: 780
• Locations: 1 country
• Sites: 1

Brief Summary

This is A Multicenter, Randomized, Double-Blind, Double-Dummy, Comparative, Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous Imipenem/Cilastatin/Funobactam in Comparison with Meropenem in Hospitalized Adults with Complicated Urinary Tract Infections, including Acute Pyelonephritis.

Conditions

Complicated Urinary Tract Infection Including Acute Pyelonephritis

Outcome Measures

Primary Outcomes (1)

• overall success

  The proportion of patients who achieve overall success at the Test of cure(TOC) visit in the micro-modified-intent-to-treat(micro-MITT) population. Overall success requires symptomatic clinical success and microbiologic success at the TOC visit.

  Day 21[±2 days]

Secondary Outcomes (7)

• overall success

  EOT: from treatment day 7 up to day 15

• overall success

  Day 28[±3 days]

• symptomatic clinical success

  Day 4; EOT: from treatment day 7 up to day 15; TOC: Day 21[±2 days]; LFU: Day 28[±3 days]

• microbiological success

  EOT: from treatment day 7 up to day 15; TOC: Day 21[±2 days]; LFU: Day 28[±3 days]

• By-pathogen microbiological success

  EOT: from treatment day 7 up to day 15; TOC: Day 21[±2 days]; LFU: Day 28[±3 days]

Study Arms (2)

Imipenem/Cilastatin/XNW4107

EXPERIMENTAL

Imipenem/Cilastatin 500mg/500mg in combination with XNW4107 250mg ,q6h(0.5h infusion)

Drug: Combination of Imipenem/Cilastatin and XNW4107

Meropenem

ACTIVE COMPARATOR

Meropenem 1g ,q8h (0.5h infusion)

Drug: Meropenem

Interventions

Combination of Imipenem/Cilastatin and XNW4107 DRUG

Imipenem/Cilastatin 500mg/500mg and XNW4107 250mg for injection

Imipenem/Cilastatin/XNW4107

Meropenem DRUG

Meropenem 1g for injection

Meropenem

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients willing and able to provide written informed consent.
• Willing and able to comply with all study assessments and adhere to the protocol schedule.
• Hospitalized or requiring hospitalization for cUTI or AP in male or female patients ≥18 years on the day of signing informed consent.
• Requiring treatment with IV antibiotic therapy.
• Evidence of AP or cUTI
• At least 1 of the following:
• Nausea or vomiting.
• Chills or rigors or warmth associated with fever (temperature \>38°C).
• Peripheral white blood cell count (WBC) \>10,000/mm³ or bandemia , regardless of WBC count.
• Having at least 1 of the following complicated factors for cUTI (not required for AP):
• Indwelling catheter of the urinary tract.
• Urinary retention.
• Any functional or anatomical abnormality of the urogenital tract resulting in at least 100 mL or more of residual urine after voiding.
• Obstructive uropathy .
• Evidence of pyuria demonstrated by 1 of the following methods:

You may not qualify if:

• Patients with any of the following conditions:
• Suspected or confirmed perinephric abscess
• Suspected or confirmed renal corticomedullary abscess
• Suspected or confirmed acute or chronic bacterial prostatitis, orchitis, or epididymitis, as determined by history and/or physical examination
• Known polycystic kidney disease or only 1 functional kidney
• Known chronic vesicoureteral reflux
• Previous renal transplantation or planned renal transplantation within 2 weeks of study entry
• Patients receiving renal replacement therapy
• Complete, permanent obstruction of the urinary tract
• Urinary tract symptoms attributable to a sexually transmitted disease.
• Gross hematuria requiring intervention other than administration of study drug.
• Urinary tract surgery within 7 days prior to randomization or urinary tract surgery planned during the study period (except surgery required to relieve an obstruction or place a stent or nephrostomy).
• Patient has any urinary catheter or device that will not be removed or replaced (if removal is not clinically acceptable) during IV therapy, including but NOT limited to indwelling bladder catheters, ureteral catheters, suprapubic catheters, J stents, and nephrostomy tubes.
• Renal function at Screening as estimated glomerular filtrated rate \<15 mL/min/1.73㎡, calculated using Modification of Diet in Renal Disease.
• Known non-urinary tract source of infection such as endocarditis, osteomyelitis, abscess, meningitis, or pneumonia diagnosed within 7 days prior to randomization.

Sponsors & Collaborators

• Evopoint Biosciences Inc.: lead

Study Sites (1)

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Interventions

Cilastatin; Meropenem

Intervention Hierarchy (Ancestors)

Cyclopropanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Thienamycins; Carbapenems; beta-Lactams; Lactams; Amides; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Jason Le

  Evopoint Biosciences Inc.

  STUDY CHAIR

Central Study Contacts

Yuanyuan Pan

CONTACT

+86 0512-89162086; xnwlcyy@evopointbio.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2022
• First Posted: January 24, 2022
• Study Start: March 30, 2023
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: February 16, 2023

Record last verified: 2023-02

Locations

US (1)